The safety and efficacy of 3% polidocanol foam and diluent in the treatment of Grade I-III hemorrhoids with bleeding: an randomized controlled clinical study
Phase 4
- Conditions
- hemorrhoids with bleeding
- Registration Number
- ChiCTR2400088702
- Lead Sponsor
- The Third People’s Hospital of Chengdu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
(1) Male or female, aged 18-75 years (including 18 and 75 years); (2) Grade I-III internal hemorrhoids with symptoms including bleeding; (3) Voluntarily participate and sign informed consent.
Exclusion Criteria
(1) Grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) Internal hemorrhoids of grade I to III are accompanied by incarceration, thrombosis, ulceration, infection and other complications; (3) Severe heart, brain, lung, liver, kidney failure can not tolerate endoscopic treatment; (4) Perianal infectious disease, anal fistula, radiotherapy history and inflammatory bowel disease during active period; (5)Ppatients allergic to Polidocanol ; (6) Pregnant women.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effectiveness of the treatment on bleeding control is evaluated at 12 and 24 weeks post-operation;The effectiveness of prolapse improvement is evaluated at 12 and 24 weeks after surgery;Endoscopy is reviewed 24 weeks after surgery and recurrence of internal hemorrhoid is assessed;
- Secondary Outcome Measures
Name Time Method